As of February 3, 2015, the CDC was aware of more than 40 patients who had received infusions of Wallcur simulated saline solution. These products are not sterile and should not be injected in humans or animals. Some patients experienced adverse events associated with these products including fever, chills, tremors, and headache. Some patients were hospitalized, and there was one death associated with the use of these products. It is not known if this death is directly related to the use of the product. Adverse events have been reported in seven states: Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado.
The FDA first became of aware of adverse events at two clinics associated with the mistaken administration of Wallcur’s simulated Practi-0.9% sodium chloride IV in late December. The FDA issued a warning to all health care providers not to inject these simulated products in humans or animals on December 30, 2014.
In a January 16 teleconference, the FDA and CDC asked state departments of health, local and county health departments, health Canada, healthcare professionals, hospitals, professional associations and others to remain vigilant for the possibility that simulated saline products remain in the pharmaceutical supply chain.
The FDA worked closely with Wallcur to change their labeling and marketing practices to prevent this from occurring again. In addition to recalling the sodium chloride IV bags, Wallcur added stickers to existing packaging and labeling to explicitly warn users that the simulated products are not intended for human or animal use and are for training purposes only. Wallcur and the FDA are continuing to discuss labeling recommendations for all simulation products.
The FDA has also reached out to other companies that market simulated products for training purposes to make them aware of this incident. The FDA has worked collaboratively with one other training company that took immediate steps to remedy potential confusion between its training products and the real drugs.
A lawsuit for the use of simulated IV solution on a patient poses a causation knot. Depending on the clarity of Wallcur’s original labelling, Wallcur could arguably be held liable. The distributors who sold the simulated IV products could be held liable, if it could be shown that they knew they were selling the simulated IV products to people who intended to administer them to patients. The FDA is evaluating the access controls in the wholesaler and distributor systems that should be in place to prevent simulated products from gaining access to the pharmaceutical supply chain.
Clinics that purchased simulated IV products would probably be the easiest target, so long as in the ordering process it was clear that what they ordered was simulated IV products as opposed to IV products for human use. The FDA noted that Sodium Chloride 0.9% Injection (IV normal saline) has been in tight supply since January 2014. Evidence of the supply shortage could be used to show that the clinics were looking for any available source.
But between the clinics purchasing the product and the patient injury there may be a causal break. Health care professionals should carefully check the labels before administering IV solutions to patients. The question becomes would an ordinary reasonable health care professional looking at the Wallcur Practi-0.9% sodium chloride solution bag know that it is not supposed to be injected into humans? If yes, the health provider’s intervening negligence may be a proximate cause of the patient’s injury.
By Sarah Kelman, JD, and the experts and editors at Medical Law Perspectives.
For more details, see the Scalpel Weekly News, January 26, 2015.
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See the CDC Update.
See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood – The Liability Risks
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe
See also Medical Law Perspectives, March 2012 Report: Off-Label Use of Prescriptions: When is this Medical Malpractice? Is the Pharmaceutical Company Liable for Overpromotion?